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Behavioral Intervention
Automated Alerts for Heart Valve Issues (ALERT Trial)
N/A
Recruiting
Led By Sreekanth Vemulapalli, MD
Research Sponsored by Tempus Labs
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
1. Mitral Regurgitation
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days from a qualifying echocardiogram indicating severe aortic stenosis or mitral regurgitation
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if using automated notifications from Tempus Next can help doctors identify and evaluate patients who may need Valve Intervention (VI). They will look at how these notifications affect whether patients undergo procedures for
Who is the study for?
This trial is for patients with severe aortic stenosis (AS) or mitral regurgitation (MR), as indicated by specific measurements on an echocardiogram. It's not for those who don't meet the required echo criteria, such as AVA ≤ 1.0 cm2 or Dimensionless index ≤ 0.25 for AS, and certain criteria for MR.
What is being tested?
The study tests if automated alerts to doctors can reduce under-treatment of severe AS and MR by comparing follow-up rates and valve surgeries between two groups: one receiving alerts and one not.
What are the potential side effects?
Since this trial involves sending automated notifications rather than drugs or medical procedures, there are no direct side effects from the intervention itself.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have mitral regurgitation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days from a qualifying echocardiogram indicating severe aortic stenosis or mitral regurgitation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days from a qualifying echocardiogram indicating severe aortic stenosis or mitral regurgitation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Establish impact of automated alerts on the hierarchical composite endpoint of valve intervention (VI) or follow-up visit with a multi-disciplinary heart team (MHT).
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Automated alertExperimental Treatment1 Intervention
Providers that will receive an automated alert sent via the EHR.
Group II: ControlActive Control1 Intervention
Care providers in the control arm will not receive an automated alert.
Find a Location
Who is running the clinical trial?
Tempus LabsLead Sponsor
16 Previous Clinical Trials
17,416 Total Patients Enrolled
MedtronicIndustry Sponsor
619 Previous Clinical Trials
761,462 Total Patients Enrolled
13 Trials studying Aortic Valve Stenosis
3,571 Patients Enrolled for Aortic Valve Stenosis
Tempus AILead Sponsor
17 Previous Clinical Trials
17,916 Total Patients Enrolled
Sreekanth Vemulapalli, MDPrincipal InvestigatorAssistant Professor of Medicine Duke University School of Medicine
2 Previous Clinical Trials
1,114 Total Patients Enrolled
Antoine Keller, MDPrincipal InvestigatorCardiothoracic Surgeon Ochsner Lafayette General Hospital
Megan Coylewright, MDPrincipal InvestigatorDirector, Structural Heart Program Erlanger Cardiology
Brian Lindman, MDPrincipal InvestigatorMedical Director, Structural Heart and Valve Center Associate Professor of Medicine Vanderbilt University Medical Center
Wayne Batchelor, MDPrincipal InvestigatorDirector of Interventional Cardiology Inova Heart and Vascular Institute
3 Previous Clinical Trials
1,664 Total Patients Enrolled